One-piece and Two-piece Zirconia Abutments in Single Implant Crowns in Esthetic Region

Partial-edentulism Clinical Trial

Official title:

Evaluation of the One-piece Zirconia Abutments and Two-piece Zirconia Abutments With Titanium Bases for Single Implant Crowns in Esthetic Region: a Randomized Split-mouth Clinical Trial With 1-year Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583123
• Other study ID #: SH9th-20-12
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Xiao-Lei Lv
• Phone: 86-18817617580
• Email: lyuxiaolei01[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trail is to evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region. The main question it aims to answer is: whether the mechanical properties of one-piece zirconia abutments are the same as those of two-piece zirconia abutments. Participants who have two missing teeth in aesthetic region will receive the OPZAs for one restoration and the TPZAs for the other. Researchers will compare OPZAs group (OG) and TPZAs group (TG) to see the clinical, radiological and immunological outcomes of the two.

Description:

Objective: To evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region. Materials and methods: The study is a single center, split-mouth and randomized controlled clinical trial. Eligible sites of patients will be randomly assigned into two groups: OPZAs group (OG) and TPZAs group (TG). Survival rates, mechanical complication rates, bleeding on probing (BOP%), probing depth (PD), modified plaque index (mPI), marginal bone loss (MBL), concentrations of pro-inflammatory cytokines (TNF-α, IL-6) in peri-implant crevicular fluid (PICF), and pink esthetics score/white esthetics score (PES/ WES) will be evaluated. Discussion: Results of the present study will help to evaluate the clinical, radiological and immunological outcomes of OPZAs and TPZAs with friction-fitted titanium bases in single implant crowns in aesthetic region and provide evidence for the effects of two types abutments on the health of peri-implant soft and hard tissue.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age=18;

2. patients with two missing teeth in esthetic region and plan to be restored with two single implant crowns;

3. adjacent to natural teeth;

4. absence of oral mucosal disease and oral infection;

5. implants with conical connection (Nobel Active, Nobel Biocare® or NobelReplace Conical Connection, Nobel Biocare®);

6. patients with the willingness to participate in the present study.

Exclusion Criteria:

1. heavy smokers (>10 cigarettes/day);

2. uncontrolled periodontitis (Full mouth plaque score>20%, full mouth bleeding score>25%, residual pocket depth>5mm);

3. with systematic diseases that may affect implant therapy, such as uncontrolled diabetes mellitus (Fasting blood-glucose>7.2mmol/L, Glycosylated hemoglobin >7%), current intake of bisphosphonates (treatment for malignancy), pregnant(or plan to get pregnant), with history of radiation therapy in head and neck region.

Related Conditions & MeSH terms

• Partial-edentulism

Intervention

Device:
• restored abutment (OPZAs)
The restorations will be restored by the OPZAs
• restored abutment (TPZAs)
The restorations will be restored with the TPZAs with friction-fitted titanium bases.

Locations

Country	Name	City	State
China	=Shanghai Ninth People's Hospital, China	Shanghai	Shanghao

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical complications rates	Veneer chipping, abutments or implants fracture, screw loosening or fracture and other mechanical complications will be recorded during the 1-year follow-up.	1 year
Secondary	Survival rates	The survival rate was defined as the percentage of success implants and remained crowns which never been replaced.	1 year
Secondary	Peri-implant conditions-BOP%	peri-implant conditions included bleeding on probing% (BOP%)	1 year
Secondary	Peri-implant conditions-PD	pocket probing depth (PD) in mm	1 year
Secondary	Peri-implant conditions-mPI	modified plaque index (mPI).	1 year
Secondary	Marginal bone loss (MBL)	Peri-apical radiographs with paralleling technique will be performed on the day of final restorations delivery and 1 year later. The implant length is used as calibration reference. The distance between restoration margin and the most coronal level of implant-bone contact will be recorded. The final result calculate as the mean value of mesial and distal sites. The alteration of the distance between baseline and 1-year follow-up is defined as the MBL.	1 year
Secondary	Pro-inflammatory cytokines in peri-implant crevicular fluid (PICF)	We will collect the patients' PICF with the paper strip (PerioPaper Strips; Oraflow Inc., Smithtown, NY, USA) at 1-year follow-up to access differences in pro-inflammatory cytokines (IL-6 and TNF-a) between two groups. Enzyme-linked immunosorbent assay (ELISA) will be used to analyzed PICF and evaluated the concentrations of cytokines. The PICF collection method and cytokines determination referred to Christopher A. Barwacz et al.	1 year
Secondary	PES	In this study, pink aesthetic score (PES) will be applied for the objective esthetic assessment of the final restoration. We will take patients' intraoral photos by the camera (D70, Nikon, Tokyo, Japan) at 1 year follow up. The aesthetic effect will be assessed by two specific dentists independently. They will asked to give scores for variables of PES (Mesial papilla, distal papilla, level of soft-tissue margin, soft-tissue contour, alveolar process and soft-tissue color and texture) and WES (Tooth form, tooth volume/outline, color, surface texture and transparency) with the 0-1-2 scoring system. Final PES/WES is the sum of the two.	1 year
Secondary	WES	In this study, white esthetic score (WES) will be applied for the objective esthetic assessment of the final restoration. We will take patients' intraoral photos by the camera (D70, Nikon, Tokyo, Japan) at 1 year follow up. The aesthetic effect will be assessed by two specific dentists independently. They will asked to give scores for variables of PES (Mesial papilla, distal papilla, level of soft-tissue margin, soft-tissue contour, alveolar process and soft-tissue color and texture) and WES (Tooth form, tooth volume/outline, color, surface texture and transparency) with the 0-1-2 scoring system. Final PES/WES is the sum of the two.	1 year